Change Control - A Practical and compliance view

Overview

The learning objectives are firstly understand the change control requirements in Pharmaceutical organisations.

The attendees will get the practical and scientific insight about the change control process in pharmaceuticals.

The benefits are:

• The person’s understanding about change control with risk based approach will be clear
• The personnel will develop the compliance approach rather than just following the existing change control systems
• The change control awareness will increase in the company

Why you should Attend

• Change control is needed to assure that changes do not impact - 
• • Product Identity, Strength, Quality, Purity, Potency
  • Validated Processes/Systems
  • Regulatory Commitments (e.g., NDA / ANDA etc.)
• To comply with cGMP requirements and guidance for change control.
• To provide a single, easy to access the source of information regarding changes for
• • Audits/Inspections
  • Annual product reviews (internal)
  • Annual reports (to FDA)

Any proposals for GMP relevant changes should be drafted, reviewed, and approved by the appropriate organizational units, and reviewed and approved by the quality unit(s). 

When implementing approved changes, measures should be taken to ensure that all documents affected by the changes are revised. 

Areas Covered in the Session

The major points covered include:

• Brief introduction of the concept
• Need for Change Control 
• Guideline expectations about Change controls EU,FDA, ICH, PIC/S, ISO etc
• PDCA Cycle in relation to Change controls
• Change Control Life cycle approach
• Types of change controls - Categorization using Heat Matrix
• Artificial Intelligence - Scope in Change Control
• cGXP Computerized systems - Scope in Change Control
• Normally missing in Change Controls learn from FDA citations
• Q&A session

Who Will Benefit

• Quality Assurance
• Quality Control
• Pharmaceutical Compliance
• Global QA
• Corporate QA and QC